A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus (T2DM)
In brief
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
Key facts
- Study ID
- NCT05761301
- Run by
- Alnylam Pharmaceuticals
- People needed
- 49
- Starts
- 2023-03-10
- Expected to finish
- 2025-04-03
- Last updated by the study team
- 2025-05-07
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
- Part A: body mass index (BMI) ≥27 kg/m\^2 and ≤34.9 kg/m\^2
- Part B: BMI ≥30 kg/m\^2 to ≤39.9 kg/m\^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%
- Part B: Confirmed T2DM diagnosis
You may not qualify if…
- Parts A and B: has received an investigational agent within the last 30 days
- Part A: History of Type 1 or Type 2 diabetes
- Part B: History of Type 1 diabetes
Where it is running
- Clinical Trial Site — Phoenix, Arizona, United States
- Clinical Trial Site — Vista, California, United States
- Clinical Trial Site — Lake Worth, Florida, United States
- Clinical Trial Site — Orlando, Florida, United States
- Clinical Trial Site — Atlanta, Georgia, United States
- Clinical Trial Site — Berlin, New Jersey, United States
- Clinical Trial Site — Monroe, North Carolina, United States
- Clinical Trial Site — Oklahoma City, Oklahoma, United States
- Clinical Trial Site — Dallas, Texas, United States
- Clinical Trial Site — Houston, Texas, United States
- Clinical Trial Site — San Antonio, Texas, United States
- Clinical Trial Site — Sarnia, Ontario, Canada
- Clinical Trial Site — Montreal, Quebec, Canada
- Clinical Trial Site — Victoriaville, Quebec, Canada
- Clinical Trial Site — Toronto, Canada
Full record on ClinicalTrials.gov
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